A Double-Blind, Randomized, Parallel, Comparative Study to Evaluate the Efficacy and Safety of an Antidiabetic Agent Repaglinide for the Treatment of Type 2 Diabetes Mellitus Patients

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Primary Purpose

Status

Unknown status

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

Repaglinide

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Treatment, Repaglinide

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Mentally competent adults of either sex with age 30-75 years old Patients have type 2 diabetes mellitus diagnosed after 25 years of age Patients have been in poor glycemic control by diet or exercise for at least 1 month or by a stable dose of metformin for at least 3 months before study; poor glycemic control is defined as: Glycosylated hemoglobin A1c (HbA1c) 7.1-11.0% Patients have signed the written informed consent form Exclusion Criteria: Patients with type 1 diabetes mellitus (insulin¬dependent) Patients taking medications possibly to affect significantly the intestinal motility or the absorption of nutrients. Female patients who are pregnant or trying to become pregnant or lactating during the study Patients with alcohol, drugs or medications abuse considered by the investigator Patients with impaired liver function (AST, ALT>2.5× upper limit of normal) Patients with impaired kidney function (serum creatinine>3.0 mg/dl) Patients with unstable cardiovascular conditions (e.g., New York Heart Association functional class III or IV congestive heart failure or a history of myocardial infarction or stroke) Patients with emphysema or chronic bronchitis Patients with diabetic ketoacidosis Patients with hepatic cirrhosis Patients with on-going inflammatory bowel disease, colonic ulceration, partial intestinal obstruction Patients are predisposed to intestinal obstruction Patients with chronic intestinal diseases related to marked disorders of digestion or absorption Patients with clinically significant medical conditions that may deteriorate clinically due to gastrointestinal gas increase Patients with a history of lactic acidosis Patients with a history of allergic to repaglinide Patients took any hypoglycemic agent except for metformin within 3 months before study Patients participated investigational drug trial within 1 month before entering this study Patients with any other serious diseases considered by the investigator not in the condition to enter the trial

Sites / Locations

National Cheng-Kung University Hospital
National Cheng-Kung University Hospital

Outcomes

Primary Outcome Measures

change of HbA1c at 12 weeks

Change of fasting plasma glucose (FPG) at 12 weeks

Change of postprandial plasma glucose (PPG) at 12 weeks

Secondary Outcome Measures

Safety parameters including adverse events such as hypoglycemia

change of liver and renal function test

Full Information

NCT ID

NCT00336310

First Posted

June 12, 2006

Last Updated

June 12, 2006

Sponsor

National Cheng-Kung University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00336310

Brief Title

A Double-Blind, Randomized, Parallel, Comparative Study to Evaluate the Efficacy and Safety of an Antidiabetic Agent Repaglinide for the Treatment of Type 2 Diabetes Mellitus Patients

Official Title

A Double-Blind, Randomized, Parallel, Comparative Study to Evaluate the Efficacy and Safety of an Antidiabetic Agent Repaglinide for the Treatment of Type 2 Diabetes Mellitus Patients

Study Type

Interventional

2. Study Status

Record Verification Date

June 2006

Overall Recruitment Status

Unknown status

Study Start Date

July 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Cheng-Kung University Hospital

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to determine whether a new-brand of repaglinide is effective in the treatment of type 2 diabetes patients.

Detailed Description

This study is designed to evaluate the efficacy and safety of a new-brand of repaglinide X® in comparison to Novonorm® for the treatment of type 2 diabetes mellitus patients. Mentally competent patients with age of 30 to 75 years old in Taiwan of either sex with type 2 diabetes mellitus will be included. All eligible subjects will be randomized into treatment groups in 1:1 ratio. The treatment will consist of either X® or Novonorm® tid before meal for 12 weeks of treatment. The primary endpoints include the net change of HbA!c, fasting plasma glucose(FPG)and postprandial plasma glucose(PPG)at the end of 12th week evaluation compared to the baseline visit. Also, safety profiles including adverse event (such as hypoglycemia) incidences, blood pressure, liver, kidney function test will be monitored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Treatment, Repaglinide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

50 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Repaglinide

Primary Outcome Measure Information:

Title

change of HbA1c at 12 weeks

Title

Change of fasting plasma glucose (FPG) at 12 weeks

Title

Change of postprandial plasma glucose (PPG) at 12 weeks

Secondary Outcome Measure Information:

Title

Safety parameters including adverse events such as hypoglycemia

Title

change of liver and renal function test

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Mentally competent adults of either sex with age 30-75 years old Patients have type 2 diabetes mellitus diagnosed after 25 years of age Patients have been in poor glycemic control by diet or exercise for at least 1 month or by a stable dose of metformin for at least 3 months before study; poor glycemic control is defined as: Glycosylated hemoglobin A1c (HbA1c) 7.1-11.0% Patients have signed the written informed consent form Exclusion Criteria: Patients with type 1 diabetes mellitus (insulin¬dependent) Patients taking medications possibly to affect significantly the intestinal motility or the absorption of nutrients. Female patients who are pregnant or trying to become pregnant or lactating during the study Patients with alcohol, drugs or medications abuse considered by the investigator Patients with impaired liver function (AST, ALT>2.5× upper limit of normal) Patients with impaired kidney function (serum creatinine>3.0 mg/dl) Patients with unstable cardiovascular conditions (e.g., New York Heart Association functional class III or IV congestive heart failure or a history of myocardial infarction or stroke) Patients with emphysema or chronic bronchitis Patients with diabetic ketoacidosis Patients with hepatic cirrhosis Patients with on-going inflammatory bowel disease, colonic ulceration, partial intestinal obstruction Patients are predisposed to intestinal obstruction Patients with chronic intestinal diseases related to marked disorders of digestion or absorption Patients with clinically significant medical conditions that may deteriorate clinically due to gastrointestinal gas increase Patients with a history of lactic acidosis Patients with a history of allergic to repaglinide Patients took any hypoglycemic agent except for metformin within 3 months before study Patients participated investigational drug trial within 1 month before entering this study Patients with any other serious diseases considered by the investigator not in the condition to enter the trial

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

H.Y. Ou, MD

Phone

886-6-2353535

Ext

2177

Email

wahoryi@mail.ncku.edu.tw

First Name & Middle Initial & Last Name or Official Title & Degree

T.J. Wu, MD

Phone

886-6-2353535

Ext

5387

Email

djwu@mail.ncku.edu.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

T-J Wu, MD

Organizational Affiliation

National Cheng-Kung University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cheng-Kung University Hospital

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Contact:

First Name & Middle Initial & Last Name & Degree

H-Y Ou, MD

Facility Name

National Cheng-Kung University Hospital

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Diabetes Mellitus, Type 2

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial